Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia

描述（由申请人提供）：手臂和手部功能受损是中风最严重和最常见的后果之一。在美国每年发生的795,000多例中风中，大约75%会导致某种程度的上肢急性瘫痪。到中风后6个月，估计65%的患者仍不能将受损的手臂和手纳入日常活动，近三分之一的患者上肢功能慢性丧失，其特征通常是无法伸展手臂和张开手。虽然上肢损伤对残疾和健康的影响很大，但旨在恢复受损上肢功能的康复干预措施相对较少。因此，我们的长期目标是开发针对麻痹性上肢的康复疗法，优化其有效性、适用性和实施性。对侧控制功能电刺激（CCFES）是一种创新的神经肌肉电刺激（NMES）治疗方法，用于改善中风后手功能的恢复。CCFES刺激患儿的手与对侧未受损手的意志张开程度成比例地张开。这使中风幸存者能够用麻痹的手进行主动重复的手张开练习、手运动控制任务和功能性任务。在这项研究中，我们增加了由对侧肘关节控制的肘关节伸肌的刺激，以改善伸展和手的张开。本研究的目的是通过增加刺激肘部伸展，增加和评估治疗时间的效果，以及估计卒中后开始治疗的最佳时间来优化CCFES。具体目的包括：1)估计手臂+手CCFES对上肢运动障碍和活动限制的影响；2)估计治疗时间的影响；3)确定治疗效果与卒中发作和治疗开始时间之间的关系。108例急性/亚急性（中风后6个月）上肢偏瘫的中风幸存者将按相同比例随机分配，接受6周、9周或12周的手臂+手部CCFES或12周的循环NMES，这是一种刺激肘部和手伸展的干预，但有预先设定的时间和强度。上肢损伤和活动限制将在基线、6、9、12、20、28和36周进行评估。通过对急性脑卒中幸存者CCFES治疗方案的优化，使CCFES治疗效果最大化，估计最佳的治疗时间和开始治疗的时间。这一信息对于设计臂+手CCFES的大规模疗效试验至关重要，并将有助于加速开发并最终推广一种减少卒中后残疾的新疗法。

DESCRIPTION (provided by applicant): Impaired arm and hand function is one of the most disabling and most common consequences of stroke. Approximately 75% of the over 795,000 strokes that occur annually in the Unites States cause some degree of upper limb paralysis acutely. By 6 months post-stroke an estimated 65% of patients still cannot incorporate the impaired arm and hand into their daily activities, and nearly one third have chronic loss of upper limb function, which is often characterized by inability to extend the arm and open the hand. While the impact of upper limb impairments on disability and health is great, there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop rehabilitation therapies for the paretic upper limb that are optimized for effectiveness, applicability, and implementation. Contralaterally Controlled Functional Electrical Stimulation (CCFES) is an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. CCFES stimulates the paretic hand to open in proportion to the degree of volitional opening of the contralateral unimpaired hand. This enables the stroke survivor to perform active repetitive hand opening exercises, hand motor-control tasks, and functional tasks with the paretic hand. In this study, we add stimulation of elbow extensors controlled by the contralateral elbow in order to improve reach as well as hand opening. The purpose of this study is to optimize CCFES by adding stimulated elbow extension, increasing and evaluating the effect of treatment duration, and estimating the best time after stroke to begin treatment. The specific aims include: 1) estimating the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation, 2) estimating the effect of treatment duration, 3) defining the relationship between treatment effect and time elapsed between stroke onset and start of treatment. One hundred eight (108) stroke survivors with acute/subacute (≤ 6 months post-stroke) upper limb hemiplegia will be randomly assigned in equal proportions to receive either 6, 9, or 12 weeks of Arm+Hand CCFES or 12 weeks of cyclic NMES, which is an intervention that stimulates the elbow and hand to extend, but with pre-set timing and intensity. Upper limb impairment and activity limitation will be assessed at baseline, 6, 9, 12, 20, 28, and 36 weeks. By optimizing the CCFES treatment for acute stroke survivors, its therapeutic effect will be maximized and the optimum treatment duration and timeframe to start treatment will be estimated. This information is critical for the design of a large-scale efficacy trial of Arm+Hand CCFES, and will serve to accelerate the development and ultimately the dissemination of a new treatment for reducing post-stroke disability.